scholarly journals Cooled (4ºC) lidocaine during office cystoscopy improves patient satisfaction and comfort: A prospective, randomized, double-blind, controlled study

2021 ◽  
Vol 15 (9) ◽  
Author(s):  
Sanjay Razdan ◽  
Rajesh Bajpai ◽  
Shirin Razdan ◽  
Marcos Sanchez-Gonzalez
Keyword(s):  
Pain Score ◽  
Room Temperature ◽  
Controlled Study ◽  
Double Blind Study ◽  
Double Blind ◽  
Significant Difference ◽  
Subjective Pain ◽  
Pain Reporting ◽  
Male Patients ◽  
And Control

Introduction: Office-based flexible cystoscopy is often associated with considerable discomfort in male patients. We devised this study to prospectively evaluate the efficacy of cooling intraurethral lidocaine jelly to 4ºC prior to use in office-based cystoscopy in an effort to reduce male patient discomfort. Methods: A total of 600 male patients scheduled for office diagnostic cystoscopy were enrolled and randomized into three groups for a prospectively controlled, double-blind study. Each group received one of the three methods of intraurethral lubrication: plain room temperature lubricant (control) (CON), room temperature lidocaine (LI), or lidocaine at 4ºC (LI4ºC). Perceived pain was recorded on a Likert visual analog scale (VAS) of 1–10 where 0=no pain and 10=excruciating pain. Kruskal-Wallis test assessed the efficacy of cooling lidocaine compared to room temperature lidocaine and control. Subjective pain reporting was corroborated with instantaneous objective pulse rate recording eliminating perception bias. Results: There was no significant difference in cystoscopy duration between all groups. Mean pain scores (mean ± standard deviation) were 4.05±0.91, 2.74±1.01, and 1.8±0.84, respectively, for groups CON, LI, and LI4ºC (p=0.02). There was a 32.34% reduction in the mean pain score of LI and a further reduction of 34.3% was achieved in LI4ºC when compared to CON. Body mass index (BMI) and prostate weight had a significant positive correlation with pain score, whereas no such correlation was found with age. Conclusions: Cooling lidocaine to 4ºC provides additional analgesic benefit in men undergoing office cystoscopy and increases compliance.

Oral Dantrolene Sodium for Tonsillectomy Pain: A Double-Blind Study

1988 ◽  
Vol 98 (1) ◽  
pp. 26-33 ◽  
Author(s):  
John R. Salassa ◽  
Samuel L. Seaman ◽  
Tibor Ruff ◽  
Armando Lenis ◽  
Edward E. Bellens ◽  
...  
Keyword(s):  
Side Effects ◽  
Activity Level ◽  
Controlled Study ◽  
Double Blind Study ◽  
Older Children ◽  
Double Blind ◽  
Dantrolene Sodium ◽  
Significant Difference ◽  
Subjective Pain ◽  
Serum Aspartate Aminotransferase

Tonsillectomy in adults and older children is typically accompanied by 7 to 14 days of pain. On the basis of clinical observations of patients treated perioperatively with dantrolene sodium for malignant hyperthermia, we hypothesized that pharyngeal muscle spasms are a major factor in tonsillectomy pain. We entered 113 patients, 11 years of age and older, into a double-blind, placebo-controlled study to evaluate the effectiveness of dantrolene sodium in reduction of tonsillectomy pain. Patients were randomly assigned either dantrolene (1.5 mg/kg per day) or placebo orally four times a day for 5 days postoperatively. On a standardized questionnaire, the patient recorded pain, diet, activity level, analgesics, and side effects, daily for 2 weeks. Also, alkaline phosphatase (alk phos) and serum aspartate aminotransferase (SGOT) levels were determined before the operation and 2 weeks after. Patients who received dantrolene had no significant differences in subjective pain, diet, or activity level scores from those of patients who received placebo. Dantrolene patients did, however, require significantly less analgesic use than placebo patients ( p = 0.034, 0.015, and 0.005 for postoperative days 2, 3, and 4, respectively). There was no significant difference in side effects or changes in liver enzyme between the dantrolene and placebo groups. We conclude that dantrolene sodium, given in the dosage noted, is effective in reduction of analgesic requirements after tonsillectomy.

Daflon 500 mg: Symptoms and Edema

Angiology ◽  
2005 ◽  
Vol 56 (6_suppl) ◽  
pp. S25-S32 ◽  
Author(s):  
Albert-Adrien Ramelet
Keyword(s):  
Quality Of Life ◽  
Controlled Study ◽  
Venous Disease ◽  
Double Blind Study ◽  
Life Questionnaire ◽  
Double Blind ◽  
Randomized Controlled ◽  
Randomized Controlled Studies ◽  
Significant Difference

Patients suffering from any class of the Clinical, Etiological, Anatomical, Pathophysiological (CEAP) classification of chronic venous disease (CVD) may be symptomatic (C0s-C6s). Leg heaviness, discomfort, itching, cramps, pain, paresthesia, and edema (C3) are the most frequent manifestations of CVD and a major reason for medical consultation. Daflon 500 mg (micronized purified flavonoid fraction [MPFF]) is an effective treatment for symptoms and edema in CVD as demonstrated in several randomized controlled studies. A 2-month, double-blind study in 40 patients established the superiority of Daflon 500 mg over placebo with regard to symptoms and objective signs. This was confirmed in another double-blind, placebo-controlled trial (2 months’ treatment, 160 patients), and in the Reflux assEssment and quaLity of lIfe improvEment with micronized Flavonoids (RELIEF) study. The latter included 5,052 patients in 23 countries, using a visual analog scale for evaluating pain, leg heaviness, cramps, and a sensation of swelling. All symptoms showed significant and progressive improvement. The quality-of-life results (scores on the ChronIc Venous Insufficiency quality of life Questionnaire [CIVIQ]) paralleled those of symptoms. The decrease in the ankle and calf circumferences was significantly greater (p<0.001) in the group of patients treated with Daflon 500 mg in two studies, and correlated well with the improvement in the sensation of swelling (p<0.001). This was confirmed with more sophisticated measurement techniques as in the RELIEF study or in a trial assessing edema with an optoelectronic volumeter in 20 patients. A further double-blind, randomized, controlled study established a statistically significant difference in favor of Daflon 500 mg in comparison with diosmin, both on symptoms and edema. The therapeutic efficacy of Daflon 500 mg on CVD symptoms and edema has been demonstrated in double-blind, randomized, controlled studies. Further studies using a new approach may define the most precise and validated methodology for application in future research in phlebology.

Pyridoxine is not effective for the prevention of hand foot syndrome (HFS) associated with capecitabine therapy: Results of a randomized double-blind placebo-controlled study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9007-9007 ◽  
Author(s):  
S. Lee ◽  
S. Lee ◽  
Y. Chun ◽  
M. Kim ◽  
H. Chang ◽  
...  
Keyword(s):  
Placebo Group ◽  
Chemotherapy Regimen ◽  
Controlled Study ◽  
Double Blind Study ◽  
Double Blind ◽  
Significant Difference ◽  
Hand Foot Syndrome ◽  
Version 2.0 ◽  
The Mean ◽  
To Receive

9007 Introduction: Although pyridoxine has been used empirically for the prevention of HFS associated with capecitabine, its efficacy has not been proven yet. We performed a prospective randomized double-blind study to determine whether pyridoxine can prevent the development of HFS when given concurrently with capecitabine. Method: Chemotherapy-naive patients (pts) with gastrointestinal tract cancers who were going to have capecitabine-containing chemotherapy were randomized to receive either oral pyridoxine (200 mg/day) or placebo daily during chemotherapy after stratified by chemotherapy regimen: 1) capecitabine alone, 2) capecitabine and cisplatin, or 3) docetaxel, capecitabine, and cisplatin. The patients were observed until grade 2 or 3 HFS (by NCI CTC version 2.0) developed or capecitabine containing chemotherapy ended. When grade 2 or 3 HFS developed in pts in placebo group, the pts were randomized again to receive either pyridoxine or placebo for next cycle of chemotherapy in order to determine whether pyridoxine could improve the HFS. Result: From Jun 2004 to Oct 2005, total 389 pts were entered onto the study. But, 29 pts (15 in placebo group and 14 in pyridoxine group) were excluded from the study because of ineligibility or pts’ refusal. Pts’ characteristics were well balanced between the 2 groups. Grade 2 or 3 HFS developed in 55 of 180 (30.6%) pts in placebo group and in 57 of 180 (31.7%) pts in pyridoxine group. (p=0.788) The median cycles of chemotherapy to grade 2 or 3 HFS was 3 in both groups. The mean cumulative dose of capecitabine until occurrence of grade 2 or 3 HFS was not different statistically between the two groups. (221,157.5 mg/m2 vs. 259,808.5 mg/m2, p=0.788). Total 44 of 55 pts in placebo group who had grade 2 or 3 HFS were randomized to receive either placebo or pyridoxine at next cycle. There was no significant difference between the two groups in the proportion of pts with improvement of HFS (43% vs 48%, p=0.94). Conclusion: These results indicated that pyridoxine is not effective for the prevention of HFS associated with capecitabine therapy. No significant financial relationships to disclose.

scholarly journals Nasal and Intravenous Administration of Dexmedetomidine to Prevent the Emergence Agitation After the Vascular Interventional Surgery in Children: A Randomized, Double-blind, Controlled Study

2020 ◽  
Author(s):  
Huang Lei ◽  
Liu Shen Ling ◽  
Pu Yanying ◽  
Peng Xiao Han ◽  
Xu Yun Bo ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Intravenous Injection ◽  
Controlled Study ◽  
Emergence Agitation ◽  
Control Groups ◽  
Double Blind ◽  
Post Surgery ◽  
Significant Difference ◽  
Nasal Drop ◽  
And Control

Abstract Introduction: Dexmedetomidine reduces the incidences of postanesthetic restlessness and hemodynamic fluctuations in children within acceptable ranges. Dexmedetomidine nasal drop prior to the surgery reduces the EA after anesthesia. There are several studies that compare the effects of dexmedetomidine nasal drop and intravenous injection, in which they were administered prior to the induction of anesthesia.This double-blind, randomized, controlled study was performed to compare the effects of dexmedetomidine nasal drop and intravenous injection on postoperative emergence agitation (EA), sedation, and hemodynamics in pediatric patients prior to and post surgery. METHODS: We randomly divided 120 children, who were enrolled in this study, into the control, dexmedetomidine nasal, and dexmedetomidine intravenous injection groups. The dexmedetomidine dose for nasal use was 2 µg / kg, and that for intravenous injection was 0.8 µg / kg. The nasal dose and the intravenous injection were, respectively, administered 30 and 10 min prior to the surgery being culminated. The EA was recorded within 30 min in the post-anesthesia care unit (PACU) and within 3 h in the ward. The incidence of EA, Ramsay scores, heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP), and adverse events were recorded. RESULTS: In the PACU, the EA incidences in the nasal dose, intravenous injection, and control groups were 27.50%, 20.00%, and 52.50%, respectively. Statistical differences between the nasal and control groups (p < 0.05, OR = 0.343, 95% CI [0.135–0.871]) and the intravenous and control groups (p < 0.05, OR = 0.226, 95% CI [0.084–0.610]) were recorded. The EA incidence was not statistically different between the nasal and intravenous injection groups. The proportions of Propofol users were 52.50%, 27.50%, and 92.50% in the nasal spray, intravenous injection, and control groups, respectively. Statistically significant differences among the three groups (p < 0.05) were observed. The EA incidences in the nasal drop, intravenous injection, and control groups in the ward were 20.00%, 17.50%, and 70.00%, respectively. Statistically significant difference between the nasal drop and control groups (p < 0.05, OR = 0.107, 95% CI [0.038–0.300]) and the intravenous and control groups (p < 0.05, OR = 0.091, 95% CI [0.032–0.262]) were found. There was no significant difference in EA incidence between the nasal drop and intravenous injection groups. CONCLUSION: Dexmedetomidine nasal and intravenous administrations have similar effects in reducing the EA incidence within 30 min in the PACU and 3 h in the ward. In the PACU the sedation depth in the intravenous injection group was greater than that in the nasal drop group and within the 3 h in the ward, the depth of sedation was the same for both administration routes. The intravenous injection affects the HR more than the nasal drop within 5 min of administration. Thus, dexmedetomidine nasal drop prior to the culmination of the surgery is more suitable for PACU and ward sedation to prevent EA. Trial registration: The registration number ,ChiCTR1900021325(http://www.chictr.org.cn/index.aspx),The date of registration,02/15/2019.

scholarly journals Prophylactic Paracetamol for Analgesia after Vaginal Termination of Pregnancy

1993 ◽  
Vol 21 (1) ◽  
pp. 93-96 ◽  
Author(s):  
L. Cade ◽  
J. Ashley
Keyword(s):  
Abdominal Pain ◽  
Postoperative Pain ◽  
Day Surgery ◽  
Termination Of Pregnancy ◽  
Blind Study ◽  
Double Blind Study ◽  
Double Blind ◽  
Negative Finding ◽  
Significant Difference ◽  
And Control

Many patients present to day surgery clinics for vaginal termination of pregnancy, a procedure which is frequently complicated by postoperative abdominal pain. We have assessed the efficacy of prophylactic paracetamol 1000 mg given orally shortly before surgery in 834 such patients in a randomised, placebo-controlled, double-blind study. Postoperative pain was reported in 35 % of patients, with no significant difference between treated and control patients. This negative finding was unexpected and is so far unexplained, given the usual efficacy of oral paracetamol in relieving this type of pain after it has occurred.

scholarly journals Caffeine Ingestion Enhances Repetition Velocity in Resistance Exercise: A Randomized, Crossover, Double-Blind Study Involving Control and Placebo Conditions

2020 ◽  
Vol 74 (1) ◽  
pp. 177-183
Author(s):  
Jozo Grgic ◽  
Sandro Venier ◽  
Brad J. Schoenfeld ◽  
Pavle Mikulic
Keyword(s):  
Bench Press ◽  
Blind Study ◽  
Double Blind Study ◽  
Control Effect ◽  
Mean Velocity ◽  
Double Blind ◽  
Caffeine Ingestion ◽  
Significant Difference ◽  
Ergogenic Effects ◽  
And Control

Abstract We aimed to examine the effects of placebo and caffeine compared to a control condition on mean velocity in the bench press exercise. Twenty-five resistance-trained men participated in this randomized, crossover, double-blind study. The participants performed the bench press with loads of 50%, 75%, and 90% of one-repetition maximum (1RM), after no supplementation (i.e., control), and after ingesting caffeine (6 mg/kg), and placebo (6 mg/kg of dextrose). At 50% 1RM, there was a significant effect of caffeine on mean velocity compared to control (effect size [ES] = 0.29; p = 0.003), but not when compared to placebo (ES = 0.09; p = 0.478). At 75% 1RM, there was a significant effect of caffeine on mean velocity compared to placebo (ES = 0.34; p = 0.001), and compared to control (ES = 0.32; p < 0.001). At 90% 1RM, there was a significant effect of caffeine on mean velocity compared to placebo (ES = 0.36; p < 0.001), and compared to control (ES = 0.46; p < 0.001). There was no significant difference between placebo and control in any of the analyzed outcomes. When evaluated pre-exercise and post-exercise, 20% to 44% and 28% to 52% of all participants identified caffeine and placebo trials beyond random chance, respectively. Given that the blinding of the participants was generally effective, and that there were no significant ergogenic effects of placebo ingestion, the improvements in performance following caffeine ingestion can be mainly attributed to caffeine’s physiological mechanisms of action.

Inhaled Terbutaline Administered via a Spacer Fully Prevents Exercise-Induced Asthma in Young Asthmatic Subjects: A Double-Blind, Randomized, Placebo-Controlled Study

1989 ◽  
Vol 17 (6) ◽  
pp. 506-513 ◽  
Author(s):  
A.T. Dinh Xuan ◽  
C. Lebeau ◽  
R. Roche ◽  
A. Ferriere ◽  
M. Chaussain
Keyword(s):  
Room Temperature ◽  
Work Load ◽  
Cycle Ergometer ◽  
Forced Expiratory Volume ◽  
Controlled Study ◽  
Adrenergic Agonist ◽  
Double Blind ◽  
Asthmatic Children ◽  
Exercise Induced ◽  
Age Range

The effects of inhaled terbutaline, a β2-adrenergic agonist, administered via a 750-ml spacer device were studied in young asthmatic subjects with exercise-induced asthma. A double-blind, randomized, placebo-controlled study of the effects of inhaled 0.5 mg terbutaline and placebo was conducted in 10 asthmatic children (age range 6–16 years) with documented exercise-induced asthma. Forced expiratory volume in 1 s (FEV1) was measured at baseline, 15 min after inhaling terbutaline or placebo, and at intervals up to 60 min after exercising. Subjects exercised using a cycle ergometer for 5 min at a submaximal, constant work-load while breathing dry air at room temperature. Terbutaline induced bronchodilation at rest in all subject and fully prevented exercise-induced asthma in nine out of the 10 subjects; the exercise-induced fall in FEV1 was markedly reduced in the remaining subject. It is concluded that exercise-induced asthma can be inhibited by pretreatment with inhaled terbutaline, administered via a spacer, in a majority of young asthmatics.

Abstract TP146: Vagus Nerve Stimulation Paired With Rehabilitation To Improve Upper Limb Function

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Jesse Dawson ◽  
Theresa J Kimberley ◽  
Gerard E Francisco ◽  
Patricia Smith ◽  
Steven C Cramer ◽  
...  
Keyword(s):  
Vagus Nerve ◽  
Upper Extremity ◽  
Nerve Stimulation ◽  
Vagus Nerve Stimulation ◽  
Human Study ◽  
Controlled Study ◽  
Eligibility Criteria ◽  
Double Blind ◽  
Upper Limb Function ◽  
Significant Difference

Introduction: Vagus Nerve Stimulation (VNS) paired with rehabilitation induces movement specific plasticity in rat motor cortex and improves forepaw function in a rat ischemic model compared to rehabilitation alone. A 20 subject first-in-human study in the UK indicated acceptable safety and feasibility of this approach in patients with arm weakness after stroke and showed a significant difference in favour of VNS paired with rehabilitation in the per-protocol analysis (Upper Extremity Fugl Meyer difference of 9.6 points for VNS vs. 3.0 Control; p = 0.038). We conducted a new, double-blind sham controlled study to further assess this technique. Methods: Subjects with chronic moderate to severe upper extremity hemiparesis secondary to ischemic stroke (Upper Extremity Fugl Meyer (UEFM) 20-50) were enrolled at four sites (3 US, 1 UK). After baseline assessments subjects were implanted with a vagus nerve stimulation device if all eligibility criteria were met. Following implantation, randomization was made to either paired VNS (1/2 second, 30 Hz., 0.8 mA, 100 uS stimulation with task-specific movement) or sham control (stimulation only on first 5 movements). All received the same intensive and task-specific rehabilitation and had 18 treatment sessions (2-hourly, 3 times a week for 6-weeks, approximately 50 repetitions per task and 300 to 400 repetition movements per session). Outcomes were assessed on the first and 30 th day following completion of the 6-week therapy course. Results: Sixteen patients (8 female) were implanted (8 VNS, 8 Control). Mean age (SD) was 63.2(6.9), with an average (SD) of 21.7 months (12.9) post stroke. One study related serious adverse event was reported (a wound infection that resolved with IV antibiotics). Blinded results (change in UEFM, WMFT, and UEFM responders for both groups) will be available and presented. Conclusions: A pivotal study of VNS paired with rehabilitation movements will be justified if preliminary results are confirmed.

scholarly journals Randomized, Double-Blind, Placebo-Controlled Study of Modified Erzhi Granules in the Treatment of Menopause-Related Vulvovaginal Atrophy

2018 ◽  
Vol 2018 ◽  
pp. 1-15
Author(s):  
Ranran Chen ◽  
Dianrong Song ◽  
Wei Zhang ◽  
Guanwei Fan ◽  
Yingqiang Zhao ◽  
...  
Keyword(s):  
Drug Withdrawal ◽  
Endometrial Thickness ◽  
Vaginal Epithelium ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Vulvovaginal Atrophy ◽  
Normal Ranges ◽  
And Control

Objective. To evaluate the clinical therapeutic efficacy and safety of modified Erzhi granules (MEG) in patients with menopause-related vulvovaginal atrophy (VVA). Methods. This randomized, double-blind, placebo-controlled study comprised two groups, including the treatment and control groups. Patients receive MEG and placebo for 12 weeks, respectively. Vaginal health score (VHS), vaginitis score, vaginal maturation index (VMI), female sexual function index (FSFI), and modified Kupperman Index (modified KI) were used as efficacy endpoints and assessed at baseline, 4, 8, and 12 weeks during administration, and 4 weeks after drug withdrawal. At baseline and 12 weeks, serum estradiol (E2), follicle stimulating hormone (FSH), pelvic ultrasound, breast ultrasound, and other safety parameters were measured, recording adverse events. Results. At 12 weeks, VHS, percentage of superficial cells in the vaginal epithelium and FSFI were significantly increased, while vaginitis score, percentage of basal cells in the vaginal epithelium, and modified KI were significantly decreased in comparison with baseline and control group (all P<0.05); these differences persisted for up to 4 weeks after drug withdrawal. The placebo group showed no significant change during treatment compared with baseline values (p>0.05). Serum E2 and FSH levels, endometrial thickness, and breast thickness in all patients were within the normal ranges before and after treatment, with no serious adverse reactions observed. Conclusion. MEG significantly alleviates menopause-related vulvovaginal atrophy, with no overt adverse effects on the endometrium, breast, hepatic, and renal functions.

Sulphadiazine/Trimethoprim Once Daily in Maxillary Sinusitis: A Randomized Double-Blind Comparison with Sulphamethoxazole/Trimethoprim B.I.D.

1981 ◽  
Vol 9 (6) ◽  
pp. 478-481 ◽  
Author(s):  
Pierre Federspil ◽  
Peter Bamberg
Keyword(s):  
Maxillary Sinusitis ◽  
Favourable Result ◽  
Double Blind Study ◽  
Double Blind ◽  
Once Daily ◽  
Days Of Therapy ◽  
Significant Difference ◽  
Blind Comparison ◽  
Cure Rates

In a randomized double-blind study fifty-four patients suffering from acute maxillary sinusitis were treated for 10 days with daily doses of sulphadiazine/trimethopim (1 g) and sulphamethoxazole/trimethoprim (1.92 g), respectively. The efficacy was evaluated clinically at two follow-up visits. X-ray investigations were performed at admission and after the therapy. Of thirty-nine patients finally evaluated, thirty-seven showed a favourable result. After 6–8 days of therapy there was significant difference in cure rates in favour of sulphadiazine/trimethoprim (p < 0.05) while the outcome as evaluated after treatment was similar for both drugs.

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